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Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries (AlterG)

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ClinicalTrials.gov Identifier: NCT03562364
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium

Brief Summary:
The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.

Condition or disease Intervention/treatment Phase
Distal Femur Fracture Tibial Plateau Fracture Distal Tibia Fracture Pilon Fracture Other: AlterG anti-gravity treadmill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries: An RCT Using the Anti-Gravity Treadmill (AlterG)
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
No Intervention: Standard of Care
The standard of care group will remain non-weight bearing for 10-12 weeks following definitive fixation and receive physical therapy in accordance with standard practice at the treating center.
Experimental: Early Advanced Weight Bearing (EAWB)
The Early Advanced Weight Bearing (EAWB) group will receive early weight-bearing treatment using the antigravity AlterG treadmill. These sessions will begin 14-28 days following definitive fixation and last for a total of 10 weeks
Other: AlterG anti-gravity treadmill
The AlterG treadmill is an FDA approved device that allows patients to perform early partial weight bearing exercises in a tightly controlled and safe environment




Primary Outcome Measures :
  1. Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: up to 12 months ]
    PROMIS Computer Adaptive Test (CAT) item banks for physical function, depression, anxiety, pain, fatigue, sleep, and social activity participation will be administered on a tablet. Scores for each item bank are calculated electronically.

  2. The Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: up to 12 months ]
    The KOOS is a 42 item assessment that evaluates joint function by asking patients to rate their symptoms and concerns in 5 domains: pain, other symptoms, function in daily living (ADL), function in sport and recreation, and foot and ankle quality of life on a scale of 0-4.

  3. Ankle Osteoarthritis Score (AOS) [ Time Frame: up to 12 months ]
    The AOS is an assessment that evaluates joint function by asking patients to rate their pain and disability while performing 18 different activities of daily living using a visual analogue scale

  4. Work Productivity and Activity Impairment (WPAI) [ Time Frame: up to 12 months ]
    Return to Usual Major Activities or Duty will be assessed by asking participants what they were doing most of the time during the previous two weeks (working/active duty, laid off/looking for work, going to school, taking care of a home etc.). If participants are working, the WPAI questionnaire will be administered. The WPAI measures work time missed and work and activity impairment because of a specified health problem during the past 7 days

  5. Range of Motion (ROM) [ Time Frame: up to 12 months ]
    Knee and ankle ROM measured with a goniometer

  6. Knee Strength [ Time Frame: up to 12 months ]
    Knee strength will be assessed with dynamometer

  7. Ankle Strength [ Time Frame: up to 12 months ]
    Ankle strength will be assessed by ability to perform heel raises

  8. The Four Square Step Test (FSST) [ Time Frame: up to 12 months ]
    This test is a dynamic test of balance and agility. It requires participants to rapidly change direction while stepping forward, backward, and sideways, over a low obstacle

  9. The Illinois Agility Test [ Time Frame: up to 12 months ]
    This is a commonly used test to measure agility by requiring the patient to turn in different directions and at different angles. The test requires the patient to navigate through a series of cones placed 3.3 meters apart as quickly as possible. It is simple test to administer and requires little equipment. The test is timed using a stopwatch and requires 10 meters of length, 5 meters of width, and 8 cones (or markers of some kind)

  10. The 5x Sit-to-Stand Test (STS5) [ Time Frame: up to 12 months ]
    This is is a commonly performed to assess lower extremity strength, endurance, and mobility. This test measures time to complete 5 full stands from a sitting position. Participants sit in a straight back chair 44.5 cm high and 38 cm deep and are asked to fold their arms across their chests and to stand up from a sitting position once. If they successfully rise, they are asked to stand up and sit down 5 times as quickly as possible. Time to stand is measured using a stopwatch. Raw scores can be transformed into a rate per minute to accurately assess change in those who were unable to perform the test at any point

  11. Timed Stair Ascent [ Time Frame: up to 12 months ]
    The timed stair ascent is an objective measure of mobility and power. Patients are asked to climb a flight of 12 stairs at their maximal rate, with or without holding onto the railing. The rater uses a stopwatch to determine the time required to reach the top of the steps

  12. Self-selected walking velocity over level terrain (SSWV-L) [ Time Frame: up to 12 months ]
    The SSWV-L is a commonly used measure of speed and general physical capacity. Subjects will be asked to walk 30 feet on a level surface, at a comfortable pace, with or without an assistive device. Use of assistive devices will be recorded, as described above. The time it takes for subjects to complete the task is measured with a stop watch and recorded as feet per second (ft/sec)

  13. 10 Meter Shuttle Run (40D) [ Time Frame: up to 12 months ]
    The 10 meter shuttle run assesses speed. Research staff will measure out a continuous 10 meter stretch that is free of obstacles. This test requires the person to run or walk back and forth between two parallel lines as fast as possible. Patients will start in a standing position and run or walk at their self-selected maximal rate 10 meters and back, for a total of 40 meters. The rater uses a stopwatch to keep time

  14. Single Leg Stance [ Time Frame: up to 12 months ]
    The single leg stance is a measure of postural stability. Participants will be asked to stand with arms crossed and pick one foot off the ground bending the knee to 90 degrees. The rater uses a stopwatch to time how long participants hold this stance, up to 60 seconds. This test is done on both legs

  15. Satisfaction with Physical Therapy and Recovery [ Time Frame: 12 month visit ]

    Satisfaction will be assessed during the final therapy visit using 3 questions designed specifically for this study:

    1. How would you rate your satisfaction with the physical therapy you received for your injury? Please choose a number from 0 to 10 with 0 being not at all satisfied and 10 being extremely satisfied.
    2. How satisfied are you with the progress you have made in recovering from your injury. Again, please use a number from 0 to 10 with 0 being not at all satisfied and 10 being extremely satisfied.
    3. Would you recommend this physical therapy program to other people with injuries like yours? Would you say definitely yes, probably yes, probably no or definitely no?

  16. Fracture Healing [ Time Frame: up to 12 months ]
    Fracture healing will be assessed by clinical and radiographic examinations.These assessments will occur (and be recorded) at any standard of care visits that include radiographic examinations even if these visits are not part of the study schedule. Healing will be determined as "healed" or "not healed" based on orthogonal radiographs examined by the treating physician

  17. Integrity of Fracture Fixation and Alignment [ Time Frame: up to 12 months ]
    Evidence of fracture fixation loss (e.g. changes in alignment, loosening of screws, fracture of implants, etc.) will be assessed at each study visit. These assessments will also occur prospectively at any other standard of care visits that include radiographic examinations. Ankle fracture alignment will be assessed by measuring the medial joint space on a mortise view radiograph (with the ankle in neutral dorsiflexion) and compared to the initial postoperative radiograph. Knee fracture alignment will be assessed by measuring the anatomic alignment on an anterior-posterior radiograph and on a lateral radiograph compared to the initial postoperative radiograph

  18. Complications [ Time Frame: up to 12 months ]
    The presence of all limb related complications will be recorded prospectively at each follow up visit, and categorized accordingly



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-55
  • Closed or Open (Gustilo Type I, II or IIIA) fractures: Distal femur (AO/OTA 33B, 33C), tibial plateau (AO/OTA 41B, 41C), or Distal tibia/pilon (AO/OTA 43B, 43C)
  • Definitively treated with a plate
  • Ambulatory prior to injury
  • Able to participate in rehab starting 28 days after definitive fixation
  • Meets AlterG requirements (4'8- 6'4; 85-400lbs)

Exclusion Criteria:

  • Medical or psychological disease that would preclude safe functional testing (e.g., severe traumatic brain injury, stroke, heart disease, etc.)
  • Prior joint trauma or disease of the operative extremity that resulted in pain, stiffness, or other limitation to mobility
  • Injury to the contra-lateral limb, upper extremities or axial skeleton that would influence single limb weight-bearing or use of an assistive device
  • Pregnancy
  • Unable to speak English
  • Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
  • Unable to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562364


Contacts
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Contact: Lisa Reider, PhD 4105023962 lsemani1@jhu.edu
Contact: Craig Remenapp, MS 4106143576 cremena1@jhu.edu

Locations
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United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Sally Morgan, BA       Sally.a.morgan6.ctr@mail.mil   
Principal Investigator: Kevin Kuhn, MD         
University of California at San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Eleni Berhaneselase       Eleni.Berhaneselase@ucsf.edu   
Principal Investigator: Saam Morshed, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Paul Stringer, BS       paul.stringer@uky.edu   
Principal Investigator: Paul Matuszewski, MD         
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Whitley Lucio       whitley.b.lucio.ctr@mail.mil   
Principal Investigator: Benjamin Potter, MD         
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: JR Westberg       Jerald.Westberg@hcmed.org   
Principal Investigator: Andrew Schmidt, MD         
United States, Texas
University of Texas Health Science Center - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Sterling Boutte       Sterling.Boutte@uth.tmc.edu   
Principal Investigator: Joshua Gary, MD         
San Antonio Military Medical Center (SAMMC) Recruiting
San Antonio, Texas, United States, 78234
Contact: Joseph Kimmel       joseph.e.kimmel2.ctr@mail.mil   
Principal Investigator: Dan Stinner, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Ashley Byrne       aeb6q@hscmail.mcc.virginia.edu   
Principal Investigator: David Weiss, MD         
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Lolita Ramsey, PhD       lolita.ramsey@inova.org   
Principal Investigator: Robert Hymes, MD         
Naval Medical Center Portsmouth Not yet recruiting
Portsmouth, Virginia, United States, 23708
Contact: Lorie Gower       lorie.m.gower.ctr@mail.mil   
Principal Investigator: Christopher Smith, MD         
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Investigators
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Principal Investigator: Daniel Stinner, MD Vanderbilt University Medical Center
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Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT03562364    
Other Study ID Numbers: W81XWH-16-2-0060 AlterG
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Major Extremity Trauma Research Consortium:
anti-gravity
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Tibial Fractures
Wounds and Injuries
Leg Injuries